Description

Famciclovir Related Compound A (20 Mg) (2-[2-(2-Amino-9H-Purin-9-Yl)Ethyl]Propane-1,3-Diol Hydrochloride) is a high-purity reference standard and pharmaceutical intermediate critical for analytical and research purposes. This compound is essential for ensuring the quality, safety, and efficacy of the antiviral drug Famciclovir through precise impurity profiling and method validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and quality control. The material is supplied as a precisely weighed 20 mg unit to guarantee convenience and accuracy for laboratory use.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Famciclovir Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Pharmaceutical Research & Development: Serves as a key intermediate or impurity marker in studies investigating the synthesis, metabolism, and stability profile of Famciclovir.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity levels as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine quality control testing to ensure Famciclovir batches meet stringent pharmacopeial (e.g., USP, EP) specifications for purity.

Basic Information

Product Name	Famciclovir Related Compound A (20 Mg) (2-[2-(2-Amino-9H-Purin-9-Yl)Ethyl]Propane-1,3-Diol Hydrochloride)
CAS No.	246021-75-0
Molecular Formula	C11H17ClN6O2
Molecular Weight	300.75 g/mol
Synonyms	2-[2-(2-Amino-9H-purin-9-yl)ethyl]-1,3-propanediol hydrochloride; 2-[2-(2-Aminopurin-9-yl)ethyl]propane-1,3-diol hydrochloride; Famciclovir Impurity A; Famciclovir Related Substance A; Penciclovir Impurity A (Hydrochloride); BRL 42810 Impurity; 9-[2,3-Dihydroxypropyl]-2-aminopurine hydrochloride
EINECS	Contact for details

Quality Control

Our Famciclovir Related Compound A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for use as a reference material. Certificates of Analysis (COA) are provided, detailing comprehensive test results against established specifications. We support compliance with cGMP and relevant pharmacopeial guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term stability, consider storage under inert atmosphere or with desiccant.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.